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and then backpackers. Business travelers are more likely to state an intention to vaccinate than other traveler types. PIN73 Soft Modelling Of Health-Related Quality Of Life Specific To Hiv In Relation To Anxiety, Depression, Personality Traits And Precariousness Aboromman M1, Lalanne C1, Dimi S2, Carrieri PM3, Reeder A1, Zucman D2, Chassany O1, Duracinsky M1 1University Paris Diderot, Paris Sorbonne Cité, Paris, France, 2Hôpital Foch, Suresnes, France, 3INSERM, Marseille, France
Objectives: Factor analysis or structural equation models (SEM) of health-related quality of life (HRQL) data generally assume a reflexive measurement model. Softmodelling techniques like SEM relying on Partial Least Squares (PLS) offer interesting alternatives. A SEM-PLS model was used to analyse the relation between anxiety/ depression, harm avoidance and quality of life among HIV patients in an online survey. Methods: Data were collected on 517 HIV+ patients (70% males, mean age 48 years) using validated self-reported measures. A structural model was posited a priori to link various domains: HRQL (PROOQL-HIV, 3 dimensions—physical, cognitive, and social health, on a 0-100 points scale), personality traits (TCI-56, 2 dimensions—harm avoidance and novelty seeking), and anxiety/depression (HADS, 2 dimensions). Participants were classified into a precarious (52%) and a non-precarious (48%) group. Two-group comparison were performed using two-tailed Student t and Pearson chi-squared tests. The SEM-PLS parameters were computed on the whole sample and regression weights (b) were compared between the two subgroups using bootstrap resampling (B= 500). Results: Univariate analysis suggest that average scores were lower (p< 0.001) in the precarious group for all dimensions of PROQOL-HIV (-14 up to -20%) and HADS (-10 and -14%) but not for harm avoidance. The PLS-PM analysis indicates that all pre-specified path coefficients were positive and significant at the 5% level. Depression was strongly associated to the cognitive (b= 0.325) and the physical (b= 0.615) dimensions of PROQOL-HIV while anxiety was strongly related to harm avoidance (b= 0.534) as expected. However, no significant differences were observed between the two groups at the level of the structural model using bootstrap resampling despite interesting variations in regression weights between the two subgroups. Conclusions: Depression is a strong predictor of lower physical, cognitive and social health but anxiety and personality traits are also potential moderators of HRQL, independent of the level of precariousness. PIN74 Analysis Of Influenza Vaccination Effectiveness In General Practitioner Lehocka L, Masarykova L, Olearova A, Koscova D Comenius University in Bratislava, Faculty of Pharmacy, Bratislava, Slovakia
Objectives: Influenza is an infectious disease causing local epidemics and infecting people of all age groups every year. Vaccination has been one of the most effective preventative measures against influenza and concomitant complications. The aim was to find out the effectiveness of flu vaccination, based on the differences in morbidity of vaccinated and unvaccinated patients. Methods: The research was done within September 2015 and February 2016 in two surgeries of general practitioners for adults in Slovakia, on the sample of 220 vaccinated and 220 unvaccinated patients. The data was acquired from the Win-Ambulance data base as well as from files of the patients. Results: Morbidity within the 220 vaccinated patients was 10,45%; while in the group of 220 unvaccinated patients it was 35,45%. The highest rate of vaccination was recorded in the age group of 59 and older with the 68,18% of patients out of 220 vaccinated patients. On the other hand; the lowest rate of vaccination was recorded in the age group of 18 - 40 years with only 5,00% of the patients out of 220 vaccinated patients. The general vaccination rate in patients in the selected surgeries of general practitioners in 2015 reached 5,71%, compared to general vaccination rate in Slovakia which was 4,6%. In contrast, the average rate of vaccination in the EU member states was 16,5%. Conclusions: We can summarize that even though the vaccination against influenza has proven to be an efficient way of prevention against this infection, the number of vaccinated patients as well as their interest to get the vaccination is decreasing in Slovakia. It is well known that flu causes increased treatment costs and hospitalization rate, missing work, as well as interruption of school and/or other social activities attendance. Vaccination has been designed to contribute to avoiding these, so besides economic benefits it can result in further social and health improvements. PIN75 Psychometric Validation Of Four Patient-Reported Outcome Instruments In A Diverse Sample Of Adults With Chronic Hepatitis C Virus Infection Treated With Simeprevir And Sofosbuvir Trigg A1, Kitchen H1, Willgoss T2, Ho KF3, Pierson RF4, Scott J5 of DRG Abacus, Manchester, UK, 3STAT-TU Inc., Toronto, ON, Canada, 4Janssen Global Services, LLC, Raritan, NJ, USA, 5Janssen Global Services, LLC, High Wycombe, UK 1DRG Abacus, Manchester, UK, 2Formerly
Objectives: To evaluate measurement properties of four patient reported outcome (PRO) instruments used in chronic hepatitis C virus (HCV) infection trials: Fatigue Severity Scale (FSS); Center for Epidemiologic Studies Depression Scale (CES-D); EuroQoL 5 Dimension (EQ-5D-5L); and HCV Symptom and Impact Questionnaire (HCV-SIQv4), a new 33-item measure of symptoms and impact of HCV and its treatment. Methods: PRO data were pooled from the IMPACT (Phase IIb) and OPTIMIST 1&2 (Phase III) trials evaluating the safety and efficacy of simeprevir in combination with sofosbuvir for treatment of chronic HCV infection. Scale range adequacy, reliability, validity, responsiveness, and thresholds for clinically important change were assessed for each PRO instrument. Results: Data from 437 patients with HCV-related liver disease severity ranging from no liver fibrosis to decompensated cirrhosis were analyzed. Stage of liver disease was associated with the severity of
symptoms and functioning at baseline. For most patients, symptom scores improved during treatment which is consistent with the reduction in HCV-related symptoms reported in the trials. Reliability was acceptable (Cronbach’s α ≥ 0.7, test-retest ICC ≥ 0.7) for most scores except the HCV-SIQv4 Gastrointestinal and Integumentary domain scores. Convergent validity was observed between PRO scores and concurrent measures of the same concept. Greater symptom severity and worse impact scores were associated with liver cirrhosis, depression, severe fatigue, and health limitations. Patients who achieved SVR12 had better outcomes on all PRO instruments. HCV-SIQv4 symptom and domain scores were responsive to improvements and worsening in health state (effect sizes ≥ 0.5). Thresholds for change in scores indicating a clinically important improvement (or worsening) were: 8 (8) for HCVSIQv4 Overall Body System Score; 1 (1) for FSS; 3 (6) for CES-D; and 8 (worsening not studied) for EQ-5D-5L VAS. Conclusions: The FSS, CES-D, EQ-5D-5L, and HCVSIQv4 are reliable, valid, and responsive measures of HCV treatment outcomes suitable for patients regardless of liver disease stage. PIN76 Psychometric Evaluation Of The Revised Hiv Treatment Satisfaction Questionnaire (Hivtsq) Romaine J1, Murray M2, Bradley C1 Psychology Research Ltd, Surrey, UK, 2ViiV Healthcare, Brentford, UK
1Health
Objectives: The HIV Treatment Satisfaction Questionnaire (HIVTSQ) is designed to measure treatment satisfaction in people living with HIV. The original 10-item HIVTSQ (Woodcock and Bradley 2001, 2006) included two five-item subscales and a 10-item scale. Given the dramatic changes in HIV treatment in the last 15 years a recent review of the HIVTSQ, following qualitative interviews, resulted in two new items concerning discomfort/pain and ease/difficulty. This abstract reports on psychometric evaluation of the revised HIVTSQ. Methods: Datasets, from two studies were available. Study 1 employed a survey design with participants recruited from the UK (N= 128) and the US (N= 127), via the internet, by Opinion Health. Study 2 included participants’ (N= 302) data from two time-points from the LATTE-2 trial (evaluating injectable treatment). All participants were HIV positive. Analyses included exploratory factor analysis (EFA) using SPSS and confirmatory factor analysis (CFA) using Mplus. Results: The underlying factor structure of the 12-item HIVTSQ was examined using EFAs and Study 1 (UK and US) data. All analyses revealed one-factor solutions, suggesting the questionnaire is best scored as a single scale. CFA of the 12-item model (using week -16 LATTE-2 data) revealed however a less than optimal model fit, suggesting a problematic association between the side-effect item and new discomfort/pain item. CFA of an alternative 11-item model (dropping discomfort/pain) revealed a good fit. Cross-validation using endpoint data from LATTE-2 and UK data from Study 1 also revealed that removal of discomfort/pain resulted in an influential improvement in the model. Conclusions: The revised HIVTSQ includes 12 items. Item 12 (discomfort/pain) however will be treated as a stand-alone item and not included in the scale score. The subscales seen previously were no longer apparent. The one-factor model of the HIVTSQ is an up-todate appropriate measure of treatment satisfaction for individuals living with HIV. PIN77 Herpes Zoster And Postherpetic Neuralgia: Quality Of Life And Healthcare Utilization, A German Study Anastassopoulou A1, Curran D2, Schmidt‐Ott R2, Schutter U3, Simon J4, Poulsen Nautrup B5, Matthews S2 1GSK, Munich, Germany, 2GSK Vaccines, Wavre, Belgium, 3Marienhospital, Marl, Germany, 4Gesundheitsnetz
Osthessen, Fulda, Germany, 5EAH-Consulting, Aachen, Germany
Objectives: To evaluate the impact of Herpes Zoster (HZ) and Post-Herpetic Neuralgia (PHN) on the disease costs and quality of life (QoL) of adults ≥ 50 years of age in Germany. Methods: This prospective, cohort study used physician network covering three geographical areas (etrack number: 113206). Health-related QoL data were collected using the EuroQoL 5D (EQ-5D) and Zoster Brief Pain Inventory (ZBPI) questionnaires. PHN was defined as a score ≥ 3 in the ZBPI worst pain item appearing or persisting ≥ 90 days after HZ rash onset day. Data on resource utilization were gathered applying the official price and tariffs for Germany in 2014. Results: 513 subjects were included in the analysis. 507 completed at least one evaluable QoL assessment. The mean age was 67.8 (Standard Deviation: 10.35) years and 63% were female. The completion rates of the QoL questionnaires were ≥ 85% at all time points up to day 90. The HZ diagnosis occurred approximately 4 days after rash onset. Mean ZBPI worst pain scores was 5.1 in all HZ subjects at day 0 and 4.4 in PHN subjects at day 90. The estimated EQ-5D disutility for the first 30 days was 0.148. PHN was experienced in 61 patients (11%); median time to PHN resolution was 276 days. Significant PHN predictors included the EQ-5D anxiety scores and Visual Analog Score (VAS) health state. HZ was accompanied by an increased use of healthcare resources. On average, 1.25 General Practitioner (GP) visits per patient were recorded (1.04 visits were chargeable to sickness funds). 91.6% of patients received ≥ 1 GP prescription, the mean drug cost per patient totaled € 54.89 for sickness funds and € 14.05 for out of pocket payments. Conclusions: HZ is associated with impaired QoL and increased health care resources use indicating a disease burden for the patient and health care system. PIN78 Impaired Quality Of Life After Chikungunya Virus Infection: A 12-Months Follow-Up Study Of Its Chronic Inflammatory Rheumatism In La Virginia, Risaralda, Colombia Rodriguez-Morales AJ1, Restrepo-Posada VM1, Acevedo-Escalante N1, Rodríguez-Muñoz ED1, Valencia-Marín M1, Castrillón-Spitia JD1, Londoño JJ2, Bedoya-Rendón HD2, CárdenasPérezJd 2, Cardona-Ospina JA1, Lagos-Grisales GJ1 1Universidad Tecnologica de Pereira, Pereira, Colombia, 2Hospital San Pedro y San Pablo, La Virginia, Colombia
Objectives: To measure the frequency of post-chikungunya (CHIK) chronic inflammatory rheumatism (pCHIK-CIR) and to assess its impact on quality of